News Media: Statements in this brief may be aributed to the Alliance for Pharmacy Compounding’s

chief execuve ocer, Sco Brunner, CAE, but we ask that reporters advise us in advance of your

intenon to quote from this document. Reach Sco at sco@a4pc.org.

*REVISED March 11, 2024: This document has been revised to provide addional informaon on the

dierence between legimate compounding and illegal online sales, to provide context related to adverse

events aributed to compounded GLP-1s, and to elaborate further on lawsuits led by drug

manufacturers against compounding pharmacies, as well as recent “open leers” from Novo and Lilly

that appear to conate legimate compounding with illegal substances in which the drug manufacturers

allege they have found impuries.

*REVISED October 11, 2023: This document has been revised to add further informaon about the

lawsuits led by Novo Nordisk and Eli Lilly against pharmacies compounding semaglude or rzepade.

*REVISED July 25, 2023: This document has been revised to remove a speculave statement about Novo

Nordisk’s ability to manufacture semaglude base; to add reference to FDA’s May 31, 2023 statement on

compounding semaglude sodium; and to add a brief discussion of lawsuits Novo Nordisk has recently

led against wellness spas and compounding pharmacies.

*REVISED May 22, 2023: This document has been revised at the request of the APC Board of Directors.

The previous version, released May 15, included our understanding of arguments made by some

compounding, pharmacists create a customized medication, most often from pure ingredients, for an

individual patient pursuant to a prescription. Pharmacists’ ability to compound medications is

authorized in federal law for good reason: While manufactured drugs are the standard, those don’t

come in strengths and dosage forms that are right for everyone, and healthcare practitioners need to be

able to prescribe customized medications when, in their judgment, a manufactured drug is not the best

course of therapy for a human or animal patient.

Compounded drugs are not “knockoffs,” “dupes,” or “counterfeits” as they have been referred to in

some recent media stories. Rather, they are legitimate therapies created from pure bulk ingredients by

pharmacies that adhere to the rigorous compounding standards of the US Pharmacopeia, are licensed

by state boards of pharmacy, and are inspected by those state boards, and sometimes by FDA as well.

medications that they believe is right for their patient.

Rough estimates are that compounded medications account for 1% to 3% of all prescriptions written in

the U.S. There’s a good chance you know someone who has benefited – or whose pet has benefited –

from a compounded drug.

What Can Be Compounded

Federal law includes criteria for what acve pharmaceucal ingredients may be used in compounded

human-health medicaons. To be eligible for compounding, an acve pharmaceucal ingredient must:

in shortage” on the FDA drug shortage webpage. This excepon is essenal for connuaon of paent

care when a drug is in shortage – as, amid connuing post-COVID supply chain issues, many are from

me to me.

GLP-1s: Semaglude and Tirzepade

In recent months, with Wegovy, Ozempic, and Mounjaro listed as “currently in shortage,” the

compounding of medicaons containing semaglude (the acve pharmaceucal ingredient in Wegovy

and Ozempic) or rzepade (the acve pharmaceucal ingredient in Mounjaro) has been a focal point in

the media and for state boards of pharmacy (which regulate tradional compounding pharmacies).

Unfortunately, many media accounts and some licensee communicaons issued by state boards have

Contrary to communicaons issued in summer 2023 by some boards of pharmacy, FDA-approved

semaglude drugs have been listed as “currently in shortage” on the FDA drug shortage list connuously

since March 2022. FDA conrmed this in a leer to the Naonal Associaon of Boards of Pharmacy in

mid-2023. FDA-approved rzepade drugs have been listed as “currently in shortage” on the FDA drug

shortage list since December 2022. “Currently in shortage” does not necessarily mean that a drug is

completely unavailable, only that there may not be sucient supply to meet demand. FDA’s formula for

determining if a drug is in shortage is the supply of the drug available divided by the demand.

Remember, FDA guidance states that if a drug is listed as “currently in shortage”— that’s the exact

language — it may be compounded. While the FDA website is indeed confusing in that it references

availability of certain drugs, availability is not menoned in the FDA guidance document addressing the

compounding of what are essenally copies of FDA-approved drugs in shortage. “Currently in shortage”

is the determinave language. To assure compliance, we advise our members who receive prescripons

We understand that Novo Nordisk, the manufacturer of Wegovy and Ozempic, and Eli Lilly, manufacturer

of Mounjaro, assert that their patents on their FDA-approved drugs prohibits the compounding of

medicaons containing the same acve pharmaceucal ingredient – and we’re aware that the

companies have led lawsuits against some compounding pharmacies. However, FDA guidance on the

compounding of copies of FDA-approved drugs when they are in shortage makes no disncon for a

patented drug. Rather, the guidance indicates that if an FDA-approved drug is listed as “currently in

shortage” on the FDA shortage list – as FDA-approved semaglude and rzepade drugs currently are –

FDA will not view a compounded version of them as “essenally a copy” of the FDA-approved drug.

Some argue that if Congress or FDA had intended there to be an excepon for patented drug, the

guidance would have stated that. While the issue has not yet been adjudicated by a court, we do note

that such an excepon for patented drugs would contradict the very reason the law allows compounding

Novo and Lilly hold patents on the API?

Asserons in news stories that the only legimate semaglude API must be obtained directly from the

manufacturers are atly incorrect. For instance, compounders of semaglude base – the acve

ingredient in Novo’s Wegovy and Ozempic – are purchasing it from registered wholesalers who are

documenng for the pharmacies that the API comes from FDA-registered manufacturers. While Novo

surely may exercise control over the supply of the API via its contracts with manufacturers, it has not

locked down the supply chain on the API – and so compounding pharmacies sll are able to access

semaglude base from FDA-registered facilies.

What about Novo’s and Lilly’s lawsuits against wellness spas and compounding pharmacies?

compounded drug by a brand name. Compounded drugs are referred to by the name of the acve

pharmaceucal ingredient. Compounded drugs are not the same as generics, and it is not accurate to

refer to them as such. Doing so is a prey clear violaon of federal law. In February 2024, a med spa and

a weight loss clinic seled with Novo. As part of the selement, permanent injuncon orders required

the two companies to stop using Novo trademarks and to disclose for 12 months that compounded

semaglude has not gone through the safety and ecacy standards required by the FDA for approved

drugs.

Novo’s suits against four compounding pharmacies – three in Florida and one in Nashville – are more

perplexing. In those suits, the word “compounding” is notably absent from the legal briefs submied to

the courts. Instead, Novo appears to be challenging the ability of compounding pharmacists to prepare

drugs that are not FDA-approved, alleging that the pharmacies are not only creang “unauthorized new

drugs” but are engaging in unfair compeon and decepve pracces that Novo says jeopardize public

health. It’s quite an accusaon. Compounding is authorized in federal law and in all 50 states – as is

proscribed from doing so has implicaons well beyond semaglude. If the state courts were to grant an

injuncon or otherwise rule in Novo’s favor in the cases against compounding pharmacies as inially

led, every single drug on the market that has never been approved by the FDA (and there are scores of

them) may be subject to a ban for Floridians and Tennesseans – and not just all compounded

medicaons.

On October 5, U.S. District Court Judge William Jung seemed to recognize the absurdity of Novo’s inial

claims and dismissed the suit against one of the four pharmacies, Brooksville Pharmacy in Florida. The

judge le open the opon for Novo to le an amended lawsuit in response, which Novo has now done.

In late November 2023, Novo led a revised claim against Brooksville and also led suit against Ocala-

Brooksville has disputed Novo’s asserons, according to a Reuters piece, and seems to have potency

tesng data to back up their push-back. Nevertheless, the judge in the case is allowing that case to

proceed to trial, but he has stated on the record that he will hold Novo accountable for its arguments

that the compounded medicaons put paents at risk.

Novo’s other asseron, that a compounding pharmacy was combining BPC-157 with semaglude, is

problemac if it’s true. It’s a near certainty that if Wells was compounding BPC-157, it’s because

physicians were prescribing it in combinaon with semaglude for their paents. Compounders don’t

prepare drugs that aren’t prescribed. Nevertheless, BPC-157 does not meet the criteria that would make

it eligible for compounding – it’s not a component of an FDA-approved drug, it doesn’t have a USP or NF

of media outlets quesoning Novo about its supposed ndings of impuries and potency problems. Has

anyone asked the drugmaker to show its work or prove what it is asserng about the compounded

semaglude prepared by the two pharmacies? How does a corporaon get its hands on a parcular drug

prescribed and dispensed to an individual paent? Was it legally acquired? How old was the drug at the

me Novo allegedly tested it? Was it stored properly in the me between being dispensed by the

compounding pharmacy and tesng? Many reporters seem to be taking it on faith that all is as Novo says

it is instead of asking to see the data, when and how were the samples obtained, etc. It could be exactly

as Novo says, but how do we know?

In addion, manufacturer Eli Lilly has led suit against 10 medical spas, wellness centers, and

compounding pharmacies selling or dispensing rzepade, the acve ingredient in Mounjaro. These

lawsuits include separate suits against compounding pharmacies in Florida and Texas claiming violaon

of federal and state consumer protecon and compeon laws – roughly idencal to the original Novo

claims against compounding pharmacies.

in the cases brought by Eli Lilly against compounding pharmacies. Each judge may decide whether to

accept the amicus.

At the heart of these legal cases is the issue of federal preempon. The drug manufacturers’ briefs fail to

menon compounding or the U.S. Food Drug & Cosmec Act or the FDA at all. Reading them, one might

think there’s no federal government, much less federal laws and regulaons not only authorizing

pharmacy compounding but also regulang the substances that can used in compounded medicaons.

Instead, the manufacturers are making claims under state laws, as if federal laws – long thought to

preempt state law when the two conict – don’t apply.

In early March 2024, both Novo and Lilly both published open leers again alleging impuries in

How can paents know that what they are geng from compounding pharmacies is in fact semaglude?

On the one hand, that’s an odd queson. Virtually no one walks into their local pharmacy to pick up their

lisinopril, uncaps the vial, and demands that the pharmacist document that those lile pink pills are in

fact what the label says they are. They almost certainly don’t ask for documentaon of where the

pharmacy sourced it (even though, for the record, tradional retail and compounding pharmacies can

answer those quesons and show documentaon readily).

On the other hand, we do understand concerns about semaglude in parcular simply because of all the

media reporng on black market sales of purported “research grade” variees of the substance (if it’s

and prescribers who want some greater assurance that the drug they’re being dispensed is what the

pharmacy says it is can ask to see the COA. In addion, paents and prescribers may ask the

compounding pharmacy whether their compounded GLP-1s have undergone third-party tesng for

potency and sterility.

What about those sketchy websites dispensing what they say is a GLP-1 drug directly to consumers?

Those aren’t pharmacies at all and shouldn’t be conated with compounding pharmacies. Legimate

compounded drugs are prescribed by a physician or other prescriber for a specic paent. They are

prepared and dispensed by state-licensed compounding pharmacies using documented pure acve

pharmaceucal ingredients that come from FDA-registered facilies. Compounding pharmacies are

authorized by federal law and follow FDA Guidance for Industry in preparing copies of FDA-approved

drugs when that drug is listed as “currently in shortage” on FDA’s Drug Shortage list – as semaglude

and rzepade currently are. FDA guidance is plainly worded on this subject.

If your doctor didn’t write you a prescripon for a compounded GLP-1 and send it to a legimate,

idenable pharmacy, beware the seller of that substance – and the substance itself. At the end of this

statement, there is a secon tled “Tips for Consumers” that can help guide you in ensuring you receive

your compounded GLP-1 from a legimate compounding pharmacy.

Some prescribers have been quoted in news reports cing a lack of clinical trial data as a reason they

won't prescribe compounded GLP-1 drugs. Is that a concern?

There are clinical trials involving compounded medicaons (many related to compounded hormone

drug – dierent dosage strengths and dosage forms – based on what a prescriber has judged that a

That notwithstanding, when it comes to semaglude, the eects of the drug are known. The prescriber

authorizing the prescripon and the pharmacist preparing the medicaon are not creang something

that has never been seen before when it comes to the drug itself. While the data from the

manufacturer’s clinical trial is technically only applicable to that manufactured product, that clinical trial

data can give a pharmacist or a prescriber some reasonable level of condence to support the use of the

API in a compounded preparaon.

Remember, too, that when you are dealing with a drug shortage, there is usually not sucient me to

pause paent care acvies and shi medicaon supplies to design a clinical trial and receive

shortage is to assure connuaon of paent care. And because the acve pharmaceucal ingredient in a

compounded drug must meet criteria in federal law, prescribers can ulize the informaon that is known

about the drug itself as the consider what is appropriate for paent care.

Some physicians have expressed concern that compounding creates risk of administraon and dosing

errors. This case report by the Utah Poison Control Center described three paents who experienced

prolonged abdominal symptoms aer taking incorrect doses of semaglude from compounding

pharmacies.

Dosing and administraon errors are a concern with all medicaons, hard stop. Pharmacists are

required to oer paent counseling, but unfortunately somemes paents or caregivers elect to forego

paent counseling. While the reported incidences cited in that link report above are unfortunate, there

are several factors about that report to consider:

Paent counseling on the appropriate use of medicaons, along with a drug ulizaon review, are

standards of care so the pharmacist and paent both understand why the paent is using a parcular

medicaon and the paent understands how to use it and the potenal risks and benets involved. This

more is known about whether semaglude sodium is an API used in either of the FDA-approved drug

products, it is APC’s posion that compounding with semaglude sodium technically is not eligible to be

used in a compounded medicaon.

Germane to this maer, following is an excerpt from FDA Guidance for Industry tled “Compounded

Drug Products That Are Essenally Copies of a Commercially Available Drug Product Under Secon 503A

As we have noted, compounding “essenally a copy” of an FDA-approved drug is permied when that

drug is listed as currently in shortage. The queson is whether semaglude compounded using

semaglude sodium “oers the same API as a commercially available drug product.”

In FDA’s April 27 leer to the Naonal Associaon of Boards of Pharmacy, FDA’s Oce of Compounding

Quality and Compliance Director Gail Bormel states that the agency is “not aware of any basis for

compounding a drug using these semaglude salts that would meet federal law requirements.” The

The Alliance for Pharmacy Compounding is the voice for pharmacy compounding, representing more

than 500 compounding small businesses – including compounding pharmacists and technicians in both

503A and 503B settings – as well as prescribers, educators, researchers, and suppliers.

In traditional compounding, pharmacists create a customized medication, most often from pure

ingredients, for an individual patient pursuant to a prescription. Pharmacists’ ability to compound

Every day, APC members play a critical role in patients’ lives, preparing essential, custom medications for

a range of health conditions, including autism, oncology, dermatology, ophthalmology, pediatrics,

women’s health, animal health, and others.